AzTrials
AzTrials

Atrioventricular BlockLEAP-BlockNCT04730921

Impact of Left Bundle Branch Area Pacing vs. Right Ventricular Pacing in Atrioventricular Block (LEAP-Block)

A study testing Left bundle branch area pacing and Right ventricular pacing in people with Atrioventricular Block and Left Bundle Branch Area Pacing, run by Fu Wai Hospital, Beijing, China at 8 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

This is a multicenter, randomized controlled study. The aim of this study is to compare the impact of LBBAP on left ventricular function as compared with traditional right ventricular pacing in patients with atrioventricular block. Read more about this study

Who is it for?
Ages 18 to 90 years
What is being tested?
Left bundle branch area pacing and Right ventricular pacing
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
486 participants
Where
8 sitesChina
Study dates
13 Nov 2020to 1 Dec 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 90 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • a. Adult patients aged 18-90;
  • b. AV block patients with ventricular pacing indications and the expected rate of ventricular pacing(VP)> 40%, including (a)Third-degree AV block; (b) Second degree AV block (type II); (c) intermittent advanced AV block with expected VP>40%; (d)Symptomatic first degree AV block and PR interval on ECG ≥ 250ms;
  • c. The subject is able to receive a pectoral implant;
  • d. The subject is willing and able to comply with the protocol;
  • e. The subject is expected to remain available for follow-up visits at the study centers.
  • f. Subject or authorized legal guardian or representative has signed and dated the study Subject Informed Consent

Who cannot join

  • a. Baseline echocardiographic assessment of patients with impaired LV function (LVEF<50%);
  • b. Having difficulties in follow-up: Those who cannot accept 2-year follow-up on time due to physical condition or other reasons;
  • c. Patients with persistent atrial fibrillation;
  • d. Pacemaker replacement without new implanted ventricular electrodes;
  • e. Patients with implantable cardioverter-defibrillator (ICD) indications;
  • f. Surgery is required within 1 year due to severe structural heart disease;
  • g. Patients with tricuspid mechanical valve replacement, or congenital heart disease (including transposition of the great arteries, or permanent left superior vena cava, etc), or AV block resulting from: (a) Hypertrophic cardiomyopathy(HCM)vpost (modified) Morrow surgery, (b) ventricular septal defect repair; and those who are unlikely to achieve successful LBBAP procedure.

Trial locations and contacts

8 sites in 1 country.

8 sites in 1 country

China8 sites

  • Beijing Anzhen hospital, Capital Medical University

    Beijing, Beijing Municipality, 100029

  • Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences

    Beijing, Beijing Municipality, 100037

  • Peking Union Medical College Hospital

    Beijing, Beijing Municipality, 100730

  • The Second Hospital of Hebei Medical University

    Shijiazhuang, Hebei

  • Tianjin Medical University General Hospital

    Tianjin, Tianjin Municipality, 300052

  • Teda International Cardiovascular Hospital

    Tianjin, Tianjin Municipality

  • Fuwai Central China Cardiovascular Hospital

    Zhengzhou, Henan, 450003

  • The First Affiliated Hospital of Zhengzhou University

    Zhengzhou, Henan, 450052

Other trials in China

About this study

Official title: Impact of Left Bundle Branch Area Pacing vs. Right Ventricular Pacing in Atrioventricular Block (LEAP-Block): A Randomized Controlled Trial

This is a multicenter, randomized controlled study. The aim of this study is to compare the impact of LBBAP on left ventricular function as compared with traditional right ventricular pacing in patients with atrioventricular block.

Read the detailed description

LEAP-BLOCK is a prospective, multi-center, randomized controlled trial that is designed to determine whether left bundle branch area pacing (LBBAP) may reduce the risk of RV ventricular pacing induced cardiac dysfunction as compared with traditional RV pacing (RVP) in patients with atrioventricular (AV) block and normal LV function (LVEF≥50%) who require high percent of ventricular pacing. The primary aim of this trial is to compare the time to first event (composite of all-cause mortality and newly heart failure hospitalization and device upgrade due to heart failure) between LBBAP and RVP group in patients with AV block. Patients with AV block and normal LV function who require high burden of ventricular pacing (expected >40%) will be randomized to LBBAP or RVP group for therapy. Patients will be followed at least every 3 months for clinical status and every 6 months for echocardiographic evaluation until the study closure.

Being tested
Left bundle branch area pacing, Right ventricular pacing
Keywords
Atrioventricular Block, Left bundle branch area pacing, Right ventricular pacing
Medical subject headings
Atrioventricular Block, Heart Failure

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Left bundle branch area pacingDevice

    Left bundle branch area pacing(LBBAP) is a novel physiological pacing form for ventricular pacing. In patients received LBBAP, the pacing lead will be placed at left bundle branch area to achieve narrow paced QRS duration.

  • Right ventricular pacingDevice

    Right ventricular pacing is the traditional pacing modality for ventricular pacing. The pacing lead was placed in the apex or septum of right ventricle.

Study groups in NCT04730921
Study groupRoleWhat they receive
LBBAP groupExperimentalAV block patients randomized to left bundle branch area pacing
Receives: Device: Left bundle branch area pacing
RVP groupActive comparatorAV block patients randomized to right ventricular pacing group
Receives: Device: Right ventricular pacing

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The primary endpoint is the time to a first event of composite outcomes, including all-cause death, hospitalization for heart failure, and an upgrade to cardiac resynchronization therapy due to pacing induced heart failure.

    All-cause death: including cardiovascular and non-cardiovascular deaths. Hospitalization for heart failure: an unplanned outpatient or emergency department visit or inpatient hospitalization in which the patient presented with signs and symptoms consistent with heart failure and required medication therapy.

    Upgrade to cardiac resynchronization therapy (CRT): Upgrade from dual-chamber pacemaker to CRT-Pacemaker/CRT-Defibrillator due to impaired LV function (LVEF decrease to 40% or less).

    Measured: Within two years after device implantation

Secondary outcomes (11)

  1. Rate of the composite outcomes of all-cause death and/or hospitalization for heart failure

    All-cause death: including cardiovascular and non-cardiovascular deaths. Hospitalization for heart failure: an unplanned outpatient or emergency department visit or inpatient hospitalization in which the patient presented with signs and symptoms consistent with heart failure and required medication therapy.

    Measured: Within 2 years after device implantation

  2. Rate of the composite outcomes of hospitalization for heart failure and/or an upgrade to cardiac resynchronization therapy due to pacing induced heart failure.

    Hospitalization for heart failure: an unplanned outpatient or emergency department visit or inpatient hospitalization in which the patient presented with signs and symptoms consistent with heart failure and required medication therapy.

    Upgrade to cardiac resynchronization therapy: Upgrade from dual chamber pacemaker to CRT-P/CRT-D due to impaired LV function (LVEF decrease to 40% or less).

    Measured: Within 2 years after device implantation

  3. Rate of the composite outcomes of LVEF <50%, and/or an increase in LVESV ≥15% during follow-up as compared with the value at randomization

    Echocardiography will be assessed every 6 month during follow-up to determine whether the LVEF is less than 50% and/or the LVESV is increased by 15% or more.

    Measured: Within 2 years after device implantation

  4. The value of LVEF and LVESV assessed by echocardiography at 1-year and 2-year follow-up

    Echocardiography will be assessed at 1-year, and 2-year follow-up and the absolute value of LVEF and LVESV will be compared between two groups.

    Measured: 24 months

  5. The time to a first event of LVEF <50% and decrease in LVEF by ≥ 10% during 2 years follow-up as compared with the value at randomization.

    Echocardiography will be assessed every 6 month during follow-up to determine whether the LVEF is less than 50% and decreased by 15% or more as compared with the value at randomization.

    Measured: 24 months

  6. The immediate success rate of the LBBAP procedure

    Successful LBBAP procedure is identified according to ECG and intracardiac electrogram (IEGM) during the procedure. All LBBAP procedures will be categorized as selective left bundle branch pacing (S-LBBP), non-selective left bundle branch pacing(NS-LBBP), or left ventricular septal pacing (LVSP).

    Measured: 1 weeks

  7. The rate of procedure and Device related complications

    Procedure complications include pneumothorax, hemothorax, and air embolism. Device related complications include lead and pocket complications.

    Measured: 24 months

  8. Changes in Pacing parameters and ECG characteristics.

    Pacing parameters include pacing thresholds (ventricle), Sense ampitude (ventricle), Impedance (ventricle). ECG characteristics include paced QRS duration and QRS morphology, etc.

    Measured: 24 months

  9. The occurrence of LV dyssynchrony

    The occurrence of LV dyssynchrony will be evaluated by echocardiography during 2-year follow-up.

    Measured: 24 months

  10. Atrial high-rate episodes recorded by the pacemaker

    Atrial high-rate episodes recorded in the pacemaker will be followed during two years of follow-up

    Measured: 24 months

  11. The long-term success rate of LBBAP

    In LBBAP group, the successful LBBAP will be identified according ECG features at 2-years follow-up

    Measured: 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Jan 2021
  2. Study start13 Nov 2020
  3. Primary completion30 Jun 2025
  4. Study completion1 Dec 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
486 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04730921
Sponsor's protocol ID
2020-1379
Acronym
LEAP-Block
Status last verified
Jul 2025
First submitted
26 Jan 2021
Last updated
30 Dec 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No

Publications

  • Yu CM, Chan JY, Zhang Q, Omar R, Yip GW, Hussin A, Fang F, Lam KH, Chan HC, Fung JW. Biventricular pacing in patients with bradycardia and normal ejection fraction. N Engl J Med. 2009 Nov 26;361(22):2123-34. doi: 10.1056/NEJMoa0907555. Epub 2009 Nov 15.

    PubMed 19915220

  • Vijayaraman P, Naperkowski A, Subzposh FA, Abdelrahman M, Sharma PS, Oren JW, Dandamudi G, Ellenbogen KA. Permanent His-bundle pacing: Long-term lead performance and clinical outcomes. Heart Rhythm. 2018 May;15(5):696-702. doi: 10.1016/j.hrthm.2017.12.022. Epub 2017 Dec 20.

    PubMed 29274474

  • Cho SW, Gwag HB, Hwang JK, Chun KJ, Park KM, On YK, Kim JS, Park SJ. Clinical features, predictors, and long-term prognosis of pacing-induced cardiomyopathy. Eur J Heart Fail. 2019 May;21(5):643-651. doi: 10.1002/ejhf.1427. Epub 2019 Feb 8.

    PubMed 30734436

  • Tayal B, Fruelund P, Sogaard P, Riahi S, Polcwiartek C, Atwater BD, Gislason G, Risum N, Torp-Pedersen C, Kober L, Kragholm KH. Incidence of heart failure after pacemaker implantation: a nationwide Danish Registry-based follow-up study. Eur Heart J. 2019 Nov 21;40(44):3641-3648. doi: 10.1093/eurheartj/ehz584.

    PubMed 31504437

  • Huang W, Su L, Wu S, Xu L, Xiao F, Zhou X, Mao G, Vijayaraman P, Ellenbogen KA. Long-term outcomes of His bundle pacing in patients with heart failure with left bundle branch block. Heart. 2019 Jan;105(2):137-143. doi: 10.1136/heartjnl-2018-313415. Epub 2018 Aug 9.

    PubMed 30093543

  • Abdelrahman M, Subzposh FA, Beer D, Durr B, Naperkowski A, Sun H, Oren JW, Dandamudi G, Vijayaraman P. Clinical Outcomes of His Bundle Pacing Compared to Right Ventricular Pacing. J Am Coll Cardiol. 2018 May 22;71(20):2319-2330. doi: 10.1016/j.jacc.2018.02.048. Epub 2018 Mar 10.

    PubMed 29535066

  • Vijayaraman P, Dandamudi G. Anatomical approach to permanent His bundle pacing: Optimizing His bundle capture. J Electrocardiol. 2016 Sep-Oct;49(5):649-57. doi: 10.1016/j.jelectrocard.2016.07.003. Epub 2016 Jul 11.

    PubMed 27457727

  • Li X, Li H, Ma W, Ning X, Liang E, Pang K, Yao Y, Hua W, Zhang S, Fan X. Permanent left bundle branch area pacing for atrioventricular block: Feasibility, safety, and acute effect. Heart Rhythm. 2019 Dec;16(12):1766-1773. doi: 10.1016/j.hrthm.2019.04.043. Epub 2019 Apr 29.

    PubMed 31048065

  • Li X, Qiu C, Xie R, Ma W, Wang Z, Li H, Wang H, Hua W, Zhang S, Yao Y, Fan X. Left bundle branch area pacing delivery of cardiac resynchronization therapy and comparison with biventricular pacing. ESC Heart Fail. 2020 Aug;7(4):1711-1722. doi: 10.1002/ehf2.12731. Epub 2020 May 13.

    PubMed 32400967

  • Sharma PS, Dandamudi G, Naperkowski A, Oren JW, Storm RH, Ellenbogen KA, Vijayaraman P. Permanent His-bundle pacing is feasible, safe, and superior to right ventricular pacing in routine clinical practice. Heart Rhythm. 2015 Feb;12(2):305-12. doi: 10.1016/j.hrthm.2014.10.021. Epub 2014 Oct 22.

    PubMed 25446158

  • Li X, Wang H, Zhang W, You L, Qiu C, Jia F, Liu Z, Li X, Wang R, Chen T, Lin W, Ren M, Cheng K, Peng H, Zhou J, Yang H, Wu Y, Zhu H, Wang Z, He C, Sun Z, Chu S, Wang Y, Li W, Zhao Y, Gold MR, Ellenbogen KA, Yao Y, Fan X; LEAP-Block Investigators. Left Bundle-Branch Area Pacing vs Right Ventricular Pacing for Atrioventricular Block and Preserved Left Ventricular Function: The LEAP-Block Randomized Clinical Trial. JAMA. 2026 Oct 28:e2618146. doi: 10.1001/jama.2026.18146. Online ahead of print.

    PubMed 42949742

Questions about this trial

What is this clinical trial studying?

A study testing Left bundle branch area pacing and Right ventricular pacing in people with Atrioventricular Block and Left Bundle Branch Area Pacing, run by Fu Wai Hospital, Beijing, China at 8 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 30 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 8 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The primary endpoint is the time to a first event of composite outcomes, including all-cause death, hospitalization for heart failure, and an upgrade to cardiac resynchronization therapy due to pacing induced heart failure. (time frame: Within two years after device implantation). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04730921, which also lists 11 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Dec 2025.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in